Oral Gel
- Product NDC
- 83650-101
- 11-digit product format
- 836500101
- Labeler code
- 83650
- Product ID
- 83650-101_299dca27-d254-e6ea-e063-6394a90a4f74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine Benzalkonium Chloride
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Savvy Care and Cosmetics
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-09-22
- Substance
- BENZOCAINE; BENZALKONIUM CHLORIDE
- Active strength
- 20; .1 g/100g; g/100g
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Oral Gel
- Brand name suffix
- Oral Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BENZOCAINE | 20 g/100g |
| BENZALKONIUM CHLORIDE | .1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| U3RSY48JW5 | Internal UNII lookup |
| F5UM2KM3W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1595155 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 05ede7e4-5a0a-c942-e063-6294a90a8a24 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 83650-101-01 | Oral GelOral Pain Relief | 42.5 g in 1 TUBE | GEL | 42.5 | 2 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SIGNATURE CARE SORE THROAT CHERRY FLAVOR | PHENOL | SAFEWAY | 94a2c1b9-f462-4489-b84a-825a82835d30 | 2026-02-23 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Meijer, Inc. | c9c17224-9304-403a-b6a1-9c8bd94e3d94 | 2026-02-19 | Warnings, Adverse reactions | M022 |
| AQUAFRESH CAVITY PROTECTION | SODIUM FLUORIDE | Haleon US Holdings LLC | 5484999c-8e6f-430d-99a5-6893a2489467 | 2026-02-16 | Warnings | M022 |
| AQUAFRESH EXTREME CLEAN WHITENING ACTION | SODIUM FLUORIDE | Haleon US Holdings LLC | aaff19d9-4ba5-462a-893b-7220feb25d6c | 2026-02-16 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | Walgreen Co. | 55807b18-42ed-45a7-845e-fcf7f5d70d04 | 2026-02-12 | Warnings, Adverse reactions | m022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Walgreen Co. | 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | 2026-02-12 | Warnings, Adverse reactions | M022 |
| PERIOSCIENCES SENSITIVE AO Pro | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | PERIOSCIENCES LLC | acca8964-b575-468c-8b40-514dfbf50778 | 2026-02-09 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | Retail Business Services, LLC | d46546d0-c6df-431a-8ab0-bc5013c084d7 | 2026-02-06 | Warnings, Adverse reactions | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | e19228e9-6f87-456e-a222-f979a234d589 | 2026-02-06 | Warnings | M022 |
| Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 49d28991-b68f-ba16-e063-6394a90a0b13 | 2026-02-02 | Warnings | M022 |
| Sootheez Strawberry Lemonade | PECTIN | Primrose Candy Co. | 49e2b303-1018-cd13-e063-6394a90ae300 | 2026-02-02 | Warnings | M022 |
| Sootheez Berry Lemonade | PECTIN | Primrose Candy Co. | 49cee56f-c45f-6c79-e063-6294a90a5f8f | 2026-02-01 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Rite Aid Corporation | 294418aa-640d-42be-ad07-de31da7a7ccc | 2026-01-30 | Warnings, Adverse reactions | M022 |
| Ora YoGu 4X Medicated Tooth and Gum Pain Reliever | MEDICATED TOOTH AND GUM PAIN RELIEVER | Kungpo Health Care & Herbal Center Inc | aa61ce6f-8336-4071-93b8-549fd22d1ae0 | 2026-01-22 | Warnings | M022 |
| Colgate Sensitive Complete Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 866067b9-3dce-492d-ae99-1b807ecd56ff | 2026-01-22 | Warnings | M022 |
| Family Wellness Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR (Family Wellness) | 92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea | 2026-01-21 | Warnings | M022 |
| Crest Pro-Health All Day Clean Breath | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 48eaca4c-19c2-2dd2-e063-6394a90a3e08 | 2026-01-21 | Warnings | M022 |
| Betadine Gargle | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 5f0a3377-1398-2603-c632-f0d214bb88ec | 2026-01-21 | Warnings | M022 |
| ORAL PAIN RELIEF | BENZOCAINE | Universal Distribution Center LLC | e276ba37-46fb-4ed9-9ee1-c08a2a89704a | 2026-01-20 | Warnings | M022 |
| Equate Orasol | 20% BENZOCAINE | WAL-MART STORES INC. | 08404780-8252-4484-b1c3-8970803f74f8 | 2026-01-19 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1595155 | benzocaine 20 % / benzalkonium chloride 0.1 % Oral Gel | PSN | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
| 1595155 | benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral Gel | SCD | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
| 1595155 | benzalkonium chloride 0.1 % / benzocaine 20 % Oral Gel | SY | 05ede7e4-5a0a-c942-e063-6294a90a8a24 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83650-101-01 | 83650010101 | 42.5 g in 1 TUBE (83650-101-01) | 42.5 g | 2023-09-22 | No | No | Current |